FDA recalls fall more than 50% in Q1 2015 after reaching record high in 2014

The analysis was performed by the Regulatory Affairs Professional Society (RAPS) using data from the FDA’s openFDA application program interface.  The 426 recalls are the second-fewest ever, given the data available (which goes back to 2013), and marks a reversal of three straight quarterly increases.

Why the decline in 2015?  RAPS explains that three huge, outlier recalls affecting 721 different models of devices made 2014 a big year for recalls.  The largest was an August recall of 233 models of devices manufactured by Puerto Rico-based device manufacturer Customed due to packaging flaws.  Although the cause and manufacturer were the same, that counts as 233 different recalls.  RAPS says that on a typical day, between 13 and 75 devices are added to the recall database.

The first quarter of 2013 had the fewest ever recalls, or 367 events in the database.

A few caveats.

The data does not show the absolute number of devices affected by the recall, only the number of different models.  A single medical device recall can affect fewer than 10 units of a device or more than 12,000, as occurred when GE recalled all of its MRI machines in one swoop because of instances in which the emergency off switch became disconnected from the machines’ superconducting magnet. And in February, Teleflex recalled nearly 16 million of its Aquapak humidifiers due to a faulty accessory whose packaging may contain foreign materials that look like black particles.

In addition, the timing of FDA’s classification and entry of a recall into the database can lag behind the actual recall by days, weeks or months.  That is because the Agency does not initiate or conduct these voluntary recalls.  They are carried out by the companies themselves.  Still, the FDA’s recall database and tools like openFDA are a handy way of keeping abreast of the industry’s ongoing safety scares.

As is typical, 92% of the recalls in the latest quarter were Class II recalls, meaning exposure to the “violative product may cause temporary or medically reversible adverse health consequences.”  Meanwhile, 4% were Class I, meaning there is a reasonable probability that the use of the recalled product “will cause serious adverse health consequences or death.”  The remainder were minor Class III recalls.

The aforementioned GE and Customed recalls were both classified as Class I.

It’s important to note there are several ways of correcting faulty devices, so not all of the recalls in the database involve returning the product to the manufacturer.

REFERENCE:  Fierce Medical Devices; 08 APR 2015; Varun Saxena

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